Executive/Asst. Manager - QA

Job Summary

Position: Executive/Asst. Manager - QA

Location

Location: Silvassa

Experience

Experience: 2 - 10 Years

Industries

Industries: Pharma

Responsibilities

• Ensure compliance with GMP, regulatory guidelines, and quality standards in pharmaceutical formulation manufacturing.
• Manage quality systems, audits, documentation, validations, and batch release while leading the QA team.
• Implement and maintain Quality Management Systems (QMS) as per USFDA, WHO-GMP, MHRA, and EU-GMP.
• Oversee deviation management, CAPA, change control, and OOS/OOT investigations.
• Conduct and lead regulatory and customer audits and ensure compliance with audit observations.
• Manage process validation, cleaning validation, and analytical method validation as per regulatory standards.
• Maintain data integrity and ensure compliance in reviewing BMR, BPR, COA, and stability studies.
• Handle vendor qualification, supplier audits, and raw material compliance.
• Lead customer complaint handling, market recalls, and root cause investigations.
• Provide GMP training, mentoring, and development of the QA team to drive quality excellence.
• Ensure effective coordination with cross-functional teams to maintain quality standards across production and QC.

Required Skills

• Strong knowledge of regulatory compliance, quality risk management, and audit handling.
• Expertise in QMS, validation processes, and documentation review.
• Excellent leadership, problem-solving, and communication skills.
• Exposed to regulatory audits.
• Exposed with Sterile / Non-sterile products formulations.
• SAP is must

Qualifications

Required Qualification: B.Pharm/M.Pharm/B.Sc/M.Sc - Chemistry

Key Skills

• Qa
• Manager